Dr. Robertson, DHA, MSc, is a senior regulatory writer and regulatory medical writing leader with more than 15 years of experience supporting global clinical and nonclinical development programs across the full product lifecycle. He has worked extensively on U.S. and international submissions, translating complex scientific, clinical, and safety data into clear, compliant, and submission-ready regulatory documentation.

As a seasoned regulatory writer, Dr. Robertson has deep hands-on experience preparing and leading a wide range of regulatory submissions and core documents, including:

• Investigational New Drug (IND) applications, including IND-enabling packages and agency-facing briefing materials

• New Drug Applications (NDA) and Biologics License Applications (BLA) supporting late-stage development and approval

• Clinical Trial Applications (CTA) for global regulatory agencies

• Clinical Study Reports (CSRs) and integrated summaries supporting pivotal and supportive studies

Dr. Robertson is particularly recognized for his expertise in the Common Technical Document (CTD), Modules 2 through 5, where he routinely authors and oversees:

• Clinical and nonclinical overviews and summaries

• Integrated summaries of safety and efficacy

• Study-level and program-level regulatory narratives aligned with FDA, EMA, and ICH expectations

Throughout his career, Dr. Robertson has held senior medical writing and leadership roles within both emerging biotechnology companies and large pharmaceutical organizations. In these roles, he has led cross-functional teams spanning regulatory affairs, clinical development, biostatistics, pharmacovigilance, and quality to ensure regulatory submissions are inspection-ready, strategically aligned, and delivered on time.

In addition to document authorship, Dr. Robertson is known for building and scaling efficient medical writing operations. His experience includes:

• Designing regulatory writing workflows, templates, and quality systems

• Establishing best practices for consistency and compliance across submissions

• Mentoring medical writers and aligning writing teams with broader regulatory strategy

Originally from New Orleans, Dr. Robertson brings a grounded, people-centered leadership style shaped by his cultural roots and professional journey. He currently resides in the Fort Lauderdale area and collaborates closely with global teams across the United States and Europe. Beyond his work as a regulatory writer, he is actively engaged in advancing the responsible integration of artificial intelligence in medical writing, with a focus on quality, transparency, and regulatory acceptability. He remains passionate about mentorship, knowledge sharing, and fostering collaborative environments where scientific rigor and innovation can thrive.

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